biostudies-literatureUnknown32Rutledge AC<h4>Objectives</h4>Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.<h4>Methods</h4>The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.<h4>Results</h4>Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.<h4>Conclusion</h4>Responses to the survey and case study demonstrated variability in lot verification practices among laboratories.Practical laboratory medicinee00300https://www.ebi.ac.uk/biostudies/studies/S-EPMC9399155biostudies-literatureLot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey.PMC9399155Bailey DChan PCBooth RAVandenberghe HStemp JRutledge ACJohnston AWaite GVeljkovic KAllen LCEdmond PAslan BLeung VDon-Wauchope AfalseLot verification practices in Ontario clinical chemistry laboratories - Results of a patterns-of-practice survey.<h4>Objectives</h4>Verifying new reagent or calibrator lots is crucial for maintaining consistent test performance. The Institute for Quality Management in Healthcare (IQMH) conducted a patterns-of-practice survey and follow-up case study to collect information on lot verification practices in Ontario.<h4>Methods</h4>The survey had 17 multiple-choice questions and was distributed to 183 licensed laboratories. Participants provided information on materials used and approval/rejection criteria for their lot verification procedures for eight classes of testing systems. The case study provided a set of lot comparison data and was distributed to 132 laboratories. Responses were reviewed by IQMH scientific committees.<h4>Results</h4>Of the 175 laboratories that responded regarding reagent lot verifications, 74% verified all tests, 11% some, and 15% none. Of the 171 laboratories that responded regarding calibrator lot verifications, 39% verified all calibrators, 4% some, and 57% none. Reasons for not performing verifications ranged from difficulty performing parallel testing to high reagent cost. For automated chemistry assays and immunoassays, 23% of laboratories did not include patient-derived materials in reagent lot verifications and 42% included five to six patient materials; 58% of laboratories did not include patient-derived materials in calibrator lot verifications and 23% included five to six patient materials. Different combinations of test-specific rules were used for acceptance criteria. For a failed lot, 98% of laboratories would investigate further and take corrective actions. Forty-three percent of laboratories would accept the new reagent lot in the case study.<h4>Conclusion</h4>Responses to the survey and case study demonstrated variability in lot verification practices among laboratories.2022-01-01T00:00:00Z2022 Nov2025-06-01T02:00:34.744Z2025-06-01T02:00:34.744ZS-EPMC93991553603532010.1016/j.plabm.2022.e00300